ImClone announces complete enrollment for Erbitux phase 3 cancer studies

By Elaine Rigoli

Tampa, Fla., Feb. 16 - ImClone Systems, Inc. announced full patient enrollment in three international, registrational phase 3 clinical trials examining the use of Erbitux (cetuximab) in three major cancer types.

The studies will examine potential survival benefit of Erbitux for patients diagnosed with colorectal cancer; head and neck cancer; and lung cancer. A combined total of more than 2,800 patients have been enrolled in these studies.

The first study, known as Epic, examines the use of Erbitux in metastatic colorectal cancer after failure of oxaliplatin-based chemotherapy. The study is being conducted to determine whether survival is prolonged in patients with metastatic colorectal cancer treated with Erbitux in combination with irinotecan compared with irinotecan alone, after best available first-line chemotherapy has failed. The 1,300 patients enrolled in this study, which began enrollment in June 2003, were recruited from 250 centers worldwide.

The second study, Extreme, will examine Erbitux as a first-line treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The study has enrolled 442 patients who were randomized to receive cisplatin/carboplatin plus 5-FU with or without Erbitux.

The third study, Flex, explores the first-line use of Erbitux in advanced non-small cell lung cancer. The study has recruited 1,124 patients with stage IIIb/IV lung cancer who had not received previous chemotherapy. Patients have been recruited from 173 centers worldwide and were randomized to receive either Erbitux in combination with standard first-line chemotherapy or standard chemotherapy alone.

"The success of an oncology product is ultimately dictated by the quality of its data. The Erbitux clinical development plan, of which these studies are the foundation, seeks to conclusively answer key questions about the drug's ability to prolong survival in a variety of settings and tumor types," said Eric K. Rowinsky, MD, ImClone chief medical officer, in a company statement.

ImClone develops biologic treatments designed to address the medical needs of patients with a variety of cancers. Headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, N.J..

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